Abemaciclib

Researchers are evaluating the effectiveness and safety of adding abemaciclib to endocrine therapy compared to endocrine therapy alone in patients with hormone receptor-positive, HER2-negative breast cancer who have had curative treatment for their first locoregional recurrence LRR. This phase III randomized trial addresses the need for better treatments after LRR, a condition that increases the risk of distant cancer spread despite the generally favorable outlook for this breast cancer type. Participants are randomly assigned to one of two groups one group receives standard endocrine therapy alone, while the other receives endocrine therapy combined with abemaciclib, a CDK46 inhibitor. Abemaciclib is taken orally at a dose of 150 mg twice daily for up to 2 years. Endocrine therapy is personalized based on menopausal status and previous treatments and may include aromatase inhibitors or tamoxifen, sometimes with ovarian function suppression. During the study, participants will be closely monitored for invasive disease-free survival over up to 9 years, including 4 years of enrollment and 5 years of follow-up. Researchers will also assess distant recurrence-free survival, breast cancer-specific survival, overall survival, and safety. Blood samples will be collected to study circulating tumor DNA as a marker for residual disease and treatment response. The total study duration allows for comprehensive evaluation of treatment effects and long-term outcomes.

Researchers are studying patients with hormone receptor-positive, HER2-negative early breast cancer HRHER2- EBC who are at high risk of their cancer returning. This observational study includes both past and future phases to assess the clinical and pathological features, treatment choices, and outcomes of patients treated with CDK46 inhibitors ribociclib or abemaciclib combined with endocrine therapy in the adjuvant setting. The study also focuses on patients whose cancer returned during or within 12 months after finishing this adjuvant treatment. Participants are those who have started or are starting adjuvant treatment with ribociclib or abemaciclib along with endocrine therapy since January 1, 2021. This study does not involve assigning treatments but observes patients receiving these therapies in real-world settings. It gathers data on treatment patterns, recurrence, and clinical outcomes without altering patient care. During the study, researchers will collect and analyze data on patient health, tumor characteristics, and treatment responses. They will track invasive disease-free survival over 3 years as the main outcome, along with distant relapse-free survival, progression-free survival, and overall survival up to 5 years. Participants will provide consent for their data to be used, and their health status will be monitored through routine medical records and follow-ups. The study is expected to continue until August 2030.

Researchers are evaluating the effectiveness and safety of dalpiciclib combined with endocrine therapy for women with early hormone receptor-positive HR and HER2-negative breast cancer. This phase 2, multicenter, randomized, open-label clinical study plans to enroll 2000 women, comparing two different doses and treatment durations of dalpiciclib alongside endocrine therapy. The studys goal is to understand how these treatments affect disease-free survival and overall outcomes in this patient group. Participants are randomly assigned to one of two groups one receives 125 mg of dalpiciclib daily for 2 years, and the other receives 100 mg daily for 3 years. Both groups take the drug in 28-day cycles, with 21 days on treatment followed by 7 days off, alongside endocrine therapy drugs selected by the investigator such as aromatase inhibitors, fulvestrant, tamoxifen, or toremifene. Treatment continues until disease progression, unacceptable side effects, withdrawal, or investigator decision. During the study, participants will have regular assessments including evaluations every 3 months in the first year and every 6 months in the second and third years to monitor patient-reported outcomes. The primary outcome is 3-year invasive disease-free survival, with secondary outcomes including distant disease-free survival, overall survival, and safety monitoring up to 30 days after treatment ends. Participants will be closely followed to assess treatment effects and side effects throughout the study duration.

Researchers are studying the combination of IN10018 and dalpiciclib to evaluate its safety, tolerability, and early signs of effectiveness in adults with progressive meningiomas. These tumors grow from membranes surrounding the brain and continue to grow or return after previous treatments. This open-label Phase Ib study aims to find a recommended dose for further research and assess how the drugs affect tumor growth and patient health. Participants will take both study drugs by mouth in 28-day cycles. IN10018 is taken once daily throughout each cycle, starting at 100 mg with a possible reduction to 50 mg if needed. Dalpiciclib is taken once daily at 125 mg for 21 days, followed by 7 days off, with a possible reduction to 100 mg. The study has two parts a dose-confirmation phase using a modified 33 design to find the best dose, and a dose-expansion phase where participants receive the recommended dose. Treatment continues until the tumor grows, side effects become unacceptable, consent is withdrawn, or other stopping reasons apply. During the study, participants will be closely monitored for side effects from the first dose through 30 days after the last dose, up to about 24 months. Researchers will measure tumor response rates, progression-free survival at 6 months, disease control rates, duration of response, and overall survival up to 36 months. Laboratory tests and biomarkers in tumor and blood samples will be assessed to understand treatment effects. Participants will be evaluated regularly to track safety and effectiveness throughout their involvement.

This research aims to understand why some patients with hormone receptor-positive breast cancer experience diarrhea when treated with Abemaciclib, a common medicine for this condition. The study focuses on the role of the natural bacteria in the gut, known as the gut microbiome, in causing this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not to learn more about this issue. The study is observational, meaning participants will continue their usual cancer treatment with Abemaciclib without receiving any new or experimental drugs. Participants will be grouped based on whether they experience diarrhea during treatment or not. The study involves collecting stool samples and optional blood samples at specific times to analyze gut bacteria types, functions, and biomarkers. Participants will provide samples and information during their treatment period, which lasts about six months on average. Researchers will assess differences in gut bacteria diversity, specific bacterial species, metabolic pathways, serum metabolites, and inflammatory markers. All personal data will be kept confidential and coded to protect privacy throughout the study.

Researchers are investigating advanced breast cancer that is hormone receptor-positive and HER2-negative, focusing on patients receiving first-line treatment with CDK46 inhibitors combined with endocrine therapy. The study is observational and multicenter, aiming to gather real-world evidence from clinical data, medical imaging, and biological samples. The study includes various sub-studies that address different aspects of treatment outcomes and patient responses. The study involves collecting data from five sub-studies real-world clinical data comparing survival outcomes among patients treated with three CDK46 inhibitors safety data on comorbidities, medications, and toxicities medical imaging analyses using CT and PET scans genomic and transcriptomic analyses from tumor samples and evaluation of treatment patterns after progression on first-line therapy. These sub-studies use different methods for data collection, extraction, and analysis to build predictive models to assist treatment decisions. Participants will have their medical records reviewed for clinical outcomes, imaging studies collected and analyzed, and biological samples obtained for molecular testing. Researchers will assess overall survival up to 120 months from treatment start, along with progression-free survival and time to subsequent treatments. The study tracks severe toxicities and gathers detailed comorbidity information to understand treatment safety. Participant involvement is based on data collection rather than active treatment assignment, with the study continuing through various follow-up periods to monitor long-term outcomes.

Researchers are examining the safety and toxicity management of Abemaciclib combined with adjuvant hormone therapy in patients with high-risk hormone receptor-positive, HER2 non-amplified localized breast cancer. This observational study focuses on a population defined by criteria from the MONARCH-E study, including patients with four or more positive axillary lymph nodes or one to three positive nodes plus either a tumor size of 5 cm or more or histological grade 3. The study aims to better understand treatment tolerance and relapse risks in a real-world setting beyond clinical trials. This retrospective study collects data from patients who have already received adjuvant Abemaciclib along with hormone therapy. The primary goal is to assess the average dose intensity of Abemaciclib over six months. Secondary objectives include evaluating recurrence-free survival, safety and tolerance of the treatment, the impact of dose reductions, and the incidence and management of digestive, hematological, and pulmonary toxicities. Additional focus is on treatment tolerance in patients over 75 years old, causes for permanent discontinuation of Abemaciclib, and quality of life impacts. Participants information is gathered retrospectively from multiple centers over a data collection period spanning May 2023 to June 2025. The study involves statistical analysis of demographic and treatment data to evaluate treatment safety and efficacy markers. The primary outcome measured is the average dose of Abemaciclib received during six months. The study will also monitor side effects according to standard classifications and assess recurrence-free survival in relation to dose adjustments. The anticipated sample size is approximately 30 patients, with inclusion lasting 23 months.

Radiation therapy is an important part of treating breast cancer, especially as newer drug treatments like HER2 inhibitors, CDK46 inhibitors, PARP inhibitors, capecitabine, and PD1 inhibitors have improved outcomes for specific groups of patients. Many patients need both radiation and ongoing drug therapy, but it is unclear if these treatments should be given at the same time. This research aims to assess the safety of giving radiation alongside these newer systemic therapies for breast cancer patients aged 18 to 70. Participants will receive radiation to the chest wall or breast area, with or without nearby lymph nodes. Alongside radiation, they will be given one of several systemic treatments including capecitabine, HER2 inhibitors such as trastuzumab and pertuzumab, CDK46 inhibitors, PARP inhibitors, or immune checkpoint inhibitors like pembrolizumab. All treatments will be administered concurrently to evaluate combined safety. The study is non-randomized and monitors patients receiving these combined therapies. During the study, participants are closely monitored for side effects, especially severe events graded as 3 or higher. Assessments occur weekly during radiation, then at 4 and 12 weeks after radiation ends, with additional checks if serious symptoms arise within three months post-radiation. Researchers record any adverse events to understand treatment safety. The study is sponsored by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, and will run until January 2027.